It’s been four years since the International Conference on Harmonization adopted ICH Q3B(R2), which harmonizes the content and qualification of impurities in drug substances, including extractables and leachables (E&L) produced by the interaction of a drug substance and its container-closure system. And yet, there still seem to be a huge amount of questions surrounding these degradation byproducts, stability testing, thresholds, and reporting requirements.

Read more »

Legislators and regulators on both sides of the Atlantic have spent the past decade trying to improve access to safe and effective pediatric formulations and drug products—but it’s unclear whether pharma companies are taking notice. Read more »

Vetter, a specialist in the aseptic filling of injection systems, opened a new 24,000-ft² facility in Chicago to manufacture preclinical, Phase I and Phase II clinical batches. The expansions, part of the new Vetter Develoment Services USA Inc., complement the company’s commercial-scale capabilities in Germany. PharmTech Europe Editor Fedra Pavlou, interviewed Peter Soelkner, managing director of Vetter Pharma International GmbH live from the AAPS 2009 show floor in Los Angeles last month. Listen to the podcast here.

See background article, “Vetter Expands Clinical- and Commercial-Scale Operations” by Patricia Van Arnum.

ISP Pharmaceuticals is embarking on a drug-solubility Initiative to support pharma companies working with poorly soluble drug actives. At a press conference held at CPhI Worldwide in Madrid, Spain, on Wednesday, the company explained that a huge amount of drugs in the pharmaceutical developmental pipeline present solubility issues. Read more »

Last week, I wrote that the increased attention to biological drugs, which are mostly taken through injections, was spurring interest in needle-free and implantable delivery methods for vaccines. Research into alternative delivery methods for vaccines could produce innovative ways of delivering other kinds of drugs as well, and I recently read about an inspired idea that a team of Boston researchers had for delivering intermittent doses of drugs. Read more »

Have you ever considered getting a flu shot but quailed at the sight of the needle? Lots of people hate getting injections, but this delivery method is still the predominant technique for administering biological drugs. Rising demand for vaccines and other biologicals is one factor spurring manufacturers to seek alternative delivery methods that could one day rescue the needlephobic. Read more »

Efforts toward drug formulations that take into account genetic makeup will require a new examination of how disease develops in the body, thereby making it possible to connect biology with the chemical functions of a drug’s active ingredient. Read more »

Pharmaceutical scientists are still just beginning to understand the working mechanisms of nano-sized particles in drug delivery. For formulators, one of the key challenges has been to design particles that increase bioavailability of the drug to specific targets but still have minimal side effects to the patient. For manufacturers, processing nanomedicines requires having to rethink traditional production operations. How do the unique properties of nano-sized particles affect the means in which they are handled, blended, mixed, coated, lyophilized? Read more »

Reports of teenagers’ pharm parties, Rush Limbaugh’s OxyContin addiction, and the questions surrounding Michael Jackson’s death have kept prescription-drug abuse in the public eye. By requiring manufacturers of opioid drugs to create risk evaluation and mitigation strategies, the US Food and Drug Administration is seeking to reduce opportunities for drug abuse while keeping the therapies available to patients who need them. One pharmaceutical company suggests that, in addition to regulatory solutions, drug abuse could be curbed using drug-delivery strategies. Read more »

My colleague Erik Greb wrote an interesting blog post yesterday about new drug delivery technology reminiscent of childhood games. Games have changed dramatically, but the concept of using them to help educate applies today. Take for example, the problem of patient compliance. A video game called “Re-Mission” (HopeLab) is helping children and teens to “blast away” cancer cells (at least on screen). The point is that it empowers the young patient to take control, which unfortunately is not the case with many adult patients with cancer. Read more »